Ureteral ObstructionPhase 4UVENTANCT01788865
Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA) in Ureteral Obstruction
A Phase 4 study testing cSEMS(Covered self-expandable dual-layered metal stent) implant in people with Ureteral Obstruction, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable dual-layered metallic mesh stent (UVENTA) in ureteral obstruction. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Ureteral Obstruction
- What is being tested?
- cSEMS(Covered self-expandable dual-layered metal stent) implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2012to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20~80 years
- One out of following cases below apply to Patients who have malignant ureteral obstruction or have benign ureteral obstruction without improvement after previous treatment
- Patients who doesn't want to have regular replacement of plastic stent
- Patients who has no improvement of obstruction after plastic stent implant
- Patients who want other Urinary diversion because of stimulatory sign or pain due to plastic stent
- Patients with no previous ureteral metal stenting procedure experience.
- Patients with more than 6 months of life expectancy
- Patients understanding the objective of the study and who are willing to sign a consent
Who cannot join
- Patients with Urothelial Carcinoma
- Patients with bladder invasion of malignant tumor
- Patients with bladder dysfunction or obstruction of lower urinary tract
- one or more times Recurrent Urinary stone in the last 3 years
- 2 or more times upper urinary tract infection without upper urinary tract obstruction
- Karnofsky scores < 60
- Patients with Bacteriuria
- Inadequate Patient to participate in the study as judged by the investigator
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Asan Medical Center
Seoul
Hyeong keoun Park, M.D. Ph.D,, +82-2-3010-3737, hkpark@amc.seoul.kr
Hyeongkeun Park, M.D. Ph.D.
- Recruiting
Samsung Medical Center
Seoul
Deokhyun Han, M.D., +82-10-9933-5125, deokhyun.han@gmail.com
Deokhyun Han, M.D.
About this study
Official title: Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA™) in Ureteral Obstruction: Prospective, Multi-center, Open Label Study
The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.
Read the detailed description
Prospective, Multi-center, open label, single arm Study
- Treatment
- Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction
- Follow up
- Assessments including X-ray(KUB), are done 3, 6, 12, 18 and 24 months after the procedure.
- Diuretic RI scan (DTPA, MAG-3) 3, 6, 12 months after the procedure
- Imaging such as IVP(Intravenous Pyelogram), ultrasonogram, CT(Computed Tomogram) are performed at 6 and 12 months.
- Conditions
- Ureteral Obstruction
- Being tested
- cSEMS(Covered self-expandable dual-layered metal stent) implant
- Keywords
- covered Metal stent, ureteral obstruction
- Medical subject headings
- Ureteral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cSEMS(Covered self-expandable dual-layered metal stent) implantDevice
Also called UVENTA™ Ureteral Stent, Taewoong medical
| Study group | Role | What they receive |
|---|---|---|
| cSEMS | Experimental | Patients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant Receives: Device: cSEMS(Covered self-expandable dual-layered metal stent) implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min)
Measured: 12 months
Secondary outcomes (6)
Technical success rate
Rate of technical success(each Ureter) resolving the stenosis and passing the contrast medium from the kidney to urinary bladder
Measured: 1week, 1 month
Final patency rate
Rate of Ureter units maintaining patency without interventions aside from re-stenting(investigational device) after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min)
Measured: 12 months
Adverse Event
Rate of total Adverse Events and Adverse Events relevant to Investigational Device
Measured: 1week, 1, 3, 6, 9, 12 months
Predictive Risk Factors for Primary patency rate
Age, Sex, type of tumor(benign/malignant), length of stenosis, location of stenosis, UVJ cross, balloon catheterization, etc.
Measured: 12 months
the primary patency rate among different location of distal stent
difference of the primary patency between the group of Distal stent located in urinary bladder and ureter
Measured: 12 months
Ureteral stent symptom questionnaire(USSQ)
Comparative analysis of USSQ : before procedure and after procedure
Measured: 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral ObstructionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Taewoong Medical Co., Ltd.
- Responsible party
- Principal investigator, HAN, DEOK HYUN, Samsung Medical Center
- Investigators
- Deok Hyun Han, M.D., Principal investigator, Department of Urology, Samsung Medical Center, Sungkyunkwan University School of MedicineHyeong keun Park, M.D. Ph.D., Principal investigator, Department of Urology, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788865
- Sponsor's protocol ID
- URT-001
- Acronym
- UVENTA
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA™) in Ureteral Obstruction: Prospective, Multi-center, Open Label Study
- ClinicalTrials.gov ID
- NCT01788865
- Acronym / sponsor ID
- UVENTA / URT-001
- Conditions
- Ureteral Obstruction
- Keywords
- covered Metal stent, ureteral obstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Taewoong Medical Co., Ltd.
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.
Detailed description
Prospective, Multi-center, open label, single arm Study
- Treatment
- Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction
- Follow up
- Assessments including X-ray(KUB), are done 3, 6, 12, 18 and 24 months after the procedure.
- Diuretic RI scan (DTPA, MAG-3) 3, 6, 12 months after the procedure
- Imaging such as IVP(Intravenous Pyelogram), ultrasonogram, CT(Computed Tomogram) are performed at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cSEMS | Experimental | Device: cSEMS(Covered self-expandable dual-layered metal stent) implantPatients with malignant ureteral obstruction have cSEMS(Covered self-expandable dual-layered metal stent) implant |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20~80 years
- One out of following cases below apply to Patients who have malignant ureteral obstruction or have benign ureteral obstruction without improvement after previous treatment
- Patients with no previous ureteral metal stenting procedure experience.
- Patients with more than 6 months of life expectancy
- Patients understanding the objective of the study and who are willing to sign a consent
Key exclusion criteria (8 listed)
- Patients with Urothelial Carcinoma
- Patients with bladder invasion of malignant tumor
- Patients with bladder dysfunction or obstruction of lower urinary tract
- one or more times Recurrent Urinary stone in the last 3 years
- 2 or more times upper urinary tract infection without upper urinary tract obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cSEMS(Covered self-expandable dual-layered metal stent) implantAlso: UVENTA™ Ureteral Stent, Taewoong medical | Device | cSEMS |
Primary outcome
Primary patency rate
Time frame: 12 months
Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ < 20 min)
6 secondary outcomes
Technical success rate
Time frame: 1week, 1 month
Final patency rate
Time frame: 12 months
Adverse Event
Time frame: 1week, 1, 3, 6, 9, 12 months
Predictive Risk Factors for Primary patency rate
Time frame: 12 months
the primary patency rate among different location of distal stent
Time frame: 12 months
Ureteral stent symptom questionnaire(USSQ)
Time frame: 1, 3, 6, 9, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deok Hyun Han, M.D. principal investigator
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Hyeong keun Park, M.D. Ph.D. principal investigator
Department of Urology, Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cSEMS(Covered self-expandable dual-layered metal stent) implant in people with Ureteral Obstruction, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deok Hyun Han, M.D. (82-2-3410-6431, deokhyun.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.